Supporting EcoPharmacoVigilance Transparency at AstraZeneca

As a result of patient use and manufacture, pharmaceuticals are found in the aquatic environment, typically in nanograms per litre concentrations. EcoPharmacoVigilance forms part of AstraZeneca’s approach to managing the safety of pharmaceuticals in the environment. The company conducts a robust environmental risk assessment for its products and reports a programme of safe discharge from manufacturing facilities in line with its water stewardship sustainability priority.

AstraZeneca also undertakes a quarterly search of the published, peer-reviewed, scientific literature for reports of detection of environmental residues of their active pharmaceutical ingredients (APIs) in order to understand real world environmental risks. Of 38 APIs included in the search, reports of measured data have been found for 25 of those APIs. These measured environmental concentrations (MECs) have been extracted and formatted for transparent visualization via the Simomics EcoPharmacoVigilance Dashboard, now live on AstraZeneca.com as part of the company’s commitment to data transparency.

The EPV Dashboard

The EcoPharmacoVigilance Dashboard, developed and maintained by Simomics Ltd, presents these MECs in a risk relationship relative to the Predicted No Effect Concentrations (PNECs) used for environmental assessment.

The information displayed can be filtered by substance, protection goal, environmental compartment or location. Citations of the original scientific literature can be found for each data point reflected on the map, by selecting a point of interest.

The relative risk posed by a substance to the environment in a specific location can be understood by its risk quotient (RQ), which is calculated using available MEC data for that location and the predicted no effect concentration (PNEC) for the substance. Where concentrations are reported for effluents prior to entry into the aquatic environment an adjustment factor of 10 is applied to account for this; consistent with dilution factors used in regulatory guidance.

PNECs mark a concentration of a substance in any environment below which adverse effects will most likely not occur during long term or short-term exposure. These values are conservative and are established based on ecotoxicology studies and additional safety factors. The PNECs displayed in the tool are based on risk to aquatic organisms only, however this will be expanded to include other protection goals in future. Where multiple MECs exist, a semi probabilistic environmental risk assessment is conducted with maximum, median, mean and 95th percentile RQs calculated.

For further information on the properties of the APIs that determine their environmental distribution and degradation and on the ecotoxicology data that informs the predicted no effect concentrations, please refer to AstraZeneca’s published environmental risk assessmentsThese sources of information show that the MECs of APIs are typically much lower than those prospectively predicted environmental concentrations (PECs) determined in our environmental risk assessments to support marketing applications and do not indicate a risk to the environment.

Please note that, while some of the APIs included are currently patent protected, others are not necessarily exclusively manufactured or distributed by AstraZeneca.

The MEC values extracted from the published literature are taken at face-value and AstraZeneca cannot accept responsibility for the quality of this data or the detection methods employed. The last literature search was performed Q1 2021. Due to limitations of the search methodology, the data included may not be comprehensive of all published information and users are invited to share any additional published data by contacting ecopharmacovigilance@astrazeneca.com.

About Simomics

Based in York since 2014, Simomics is an ethics-led software technology SME, driven by a strong mission and purpose to promote corporate environmental responsibility, and the replacement, reduction, and refinement of the use of animals for scientific purposes through in-silico modelling. Combining world leading expertise in life science, software engineering and data science, Simomics works with global clients and partners in the pharmaceutical, agrochemical, personal care and environmental industries.

Simomics develop technologies to explore, communicate and maximise the value from computer based (in-silico) models to accelerate and de-risk R&D, support environmental protection initiatives and predict and mitigate the effects of pharmaceuticals and chemicals in the environment.

Simomics have previously collaborated with AstraZeneca and the University of York, with funding from Innovate UK, to develop the VFETL Virtual Fish EcoToxicology Laboratory to explore the eco-toxicological effects of legacy and new drugs and minimise the need for fish trials. Simomics are now developing the database and Digital Assessment System at the heart of the PREMIER IMI2 project for the prioritization and risk evaluation of APIs in the environment, working alongside a consortium of academic and industry organisations and pharmaceutical companies including AstraZeneca.

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